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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 2 APPLICATION; FLASH GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 2 APPLICATION; FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71733-01
Device Problem Computer Software Problem (1112)
Patient Problem Insufficient Information (4580)
Event Date 02/03/2022
Event Type  Injury  
Manufacturer Narrative
The product data has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The date the incident occurred is unknown.The date entered in is the date abbott diabetes care became aware of the event.The device mfg date is unknown.The date entered in is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
Caregiver reported not receiving notifications on freestyle libre 2 application and due to this, the customer experienced a medical event which required treatment.No further information was provided.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
The user reported that they are unable to receive notifications in librelinkup.Attempts to replicate the users compaint using a similar configuration was performed and notifications were received after scanning a sensor.Investigation was unable to replicate the complaint therefore, the issue is not confirmed.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.The date the incident occurred is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.The device manufacturing date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.
 
Event Description
Caregiver reported not receiving notifications on freestyle libre 2 application and due to this, the customer experienced a medical event which required treatment.No further information was provided.There was no report of death or permanent injury associated with this event.
 
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Brand Name
FREESTYLE LIBRE 2 APPLICATION
Type of Device
FLASH GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE LTD
range road
witney 12345 -700
UK  12345-7001
Manufacturer Contact
audra fuentes
1360 south loop road
alameda, CA 94502-7001
5107495297
MDR Report Key13640160
MDR Text Key286426598
Report Number2954323-2022-06832
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K201761
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71733-01
Device Lot Number2.5.3.3088
Was Device Available for Evaluation? No
Date Manufacturer Received03/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/03/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexMale
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